Senior Medical Device Quality Engineer

3 days ago

Galway, Galway, Ireland beBeeQuality Full time €80,000 - €150,000

Thriving quality engineer sought for 6-month contract position in medical device manufacturing. A seasoned professional with extensive experience in process validation, CAPA/NCR management, and problem-solving is required to lead our team.

">Key Responsibilities
  • Collaborate with manufacturing process owners to identify and rectify compliance gaps.
  • Support manufacturing process validation activities (IQ/OQ/PQ).
  • Update quality system documentation and technical files to ensure readiness for audits.
  • Drive closure of CAPAs and NCRs with effective corrective actions.
  • Provide clear and concise technical writing for quality and manufacturing procedures.
  • Cultivate cross-functional relationships with Quality, Manufacturing, and Regulatory teams to implement compliant solutions.
Qualifications & Experience
  • Bachelor's degree in Engineering or a related field.
  • 25 years of experience in medical device manufacturing, quality, or remediation projects.
  • Strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management.
  • Proven ability to write technical documents.
  • Familiarity with 21 CFR Part 820 and ISO 13485 quality standards.

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